- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05248100
Rudi Kundini, Pamoja Kundini: Fase I (RKPK: Phase I)
Fortalecimiento de la continuidad de la atención del VIH en Tanzania con apoyo económico: Fase I
This protocol describes a 2-arm cluster, randomized controlled trial designed to test the effectiveness of a conditional cash transfer on viral suppression at 6 months among people living with HIV infection (PLHIV) in Tanzania who have disengaged from HIV care. Randomization will take place at the clinic level (HIV primary care clinics). The comparison group receives standard of care standard of care HIV tracing services according to Tanzania's National Guidelines for the Management of HIV and the Ministry of Health to locate potential participants, including home based care (HBC) tracing of PLHIV who have disengaged from primary care, the provision of counseling to return to HIV care, and the offer to schedule an HIV primary care appointment on the spot. Eligible adult PLHIV disengaged from HIV care and living in an intervention facility catchment area will receive the same standard of care HIV tracing and clinical services as control participants, plus the opportunity to receive a one-time cash transfer incentive, conditional upon confirmed completion of a clinical visit if within 90 days of study enrollment. The primary endpoint is viral suppression (<1000 copies/ml) at 6 months after study enrollment.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The overall objective of this study is to evaluate the effectiveness of a home visit plus one-time financial incentive on the proportion of out of care PLHIV with viral load suppression (<1000 copies/ml) at 6 months after study enrollment. We will use a cluster, randomized controlled trial design with a sample size of 20 PLHIV in each of the 32 health facility catchment areas (N=640 PLHIV total) to examine the effect of a home visit plus one-time financial incentive on the primary outcome of viral suppression at 6 months. The study will take place across Geita and Kagera Regions (Lake Zone) in Tanzania.
This study will follow standard of care HIV tracing services according to Tanzania's National Guidelines for the Management of HIV and the Ministry of Health to locate potential participants, including home based care (HBC) tracing of PLHIV who have disengaged from primary care, the provision of counseling to return to HIV care, and the offer to schedule an HIV primary care appointment on the spot. Eligible and consenting participants living in an intervention health facility catchment area will receive the same standard of care HIV tracing and clinical services as control participants, plus the opportunity to receive a one-time incentive of 22,500 TSH (~$10 USD), with half (11,250 TSH) delivered upon enrollment in the study and half delivered after confirmation of the completion of a clinical visit if within 90 days of study enrollment.
Primary Endpoint:
1. Viral suppression (<1000 copies/ml) at 6 months after enrollment
Secondary Endpoints:
- Viral suppression at 12 months after enrollment
- Durable viral suppression at 12 months after enrollment
- Appointment attendance
- Time to re-linkage to care
- Mortality at 12 months after enrollment
- Re-linkage to care at 12 months after enrollment
- Retention at 6 and 12 months, defined as the proportion of PLHIV on antiretroviral therapy (ART) at 6 months after enrollment and 12 months after enrollment, respectively
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
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Geita, Tanzania
- Geita Region
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Kagera, Tanzania
- Kagera Region
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- PLHIV living in the catchment area of a study health facility;
- Age 18 years or older;
- Phone ownership OR phone consistent phone access;
- Classified as lost to follow up (LTFU) from HIV care (not attended a clinic appointment for ≥28 days since last scheduled appointment);
- Has had a clinic appointment within the last 24 months, and
- Provides written informed consent for participation
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Conditional Cash Transfer
Eligible and consenting participants living in an intervention health facility catchment area will receive the same standard of care HIV tracing and clinical services as control participants, plus the opportunity to receive a one-time incentive of 22,500 Tanzanian Shillings (TSH) (~$10), with half (11,250 TSH) delivered upon enrollment in the study and half delivered after confirmation of the completion of a clinical visit if within 90 days of study enrollment. |
The intervention is a one-time cash transfer of 22,500 Tanzanian Shillings (~$10), with half (11,250 TSH) delivered upon enrollment in the study and half delivered after confirmation of the completion of a clinical visit if within 90 days of study enrollment. |
|
Sin intervención: Control
Eligible and consenting participants living in a control health facility catchment area will receive the standard of care HIV tracing and clinical services. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of Participants With 6-month Viral Suppression
Periodo de tiempo: 6 months
|
The proportion of people living with HIV (PLHIV) retained in HIV primary care and with suppressed HIV viral load 6 months following study enrollment. The primary outcome is expressed as a binary variable, defined as PLHIV who are on ART and with sufficient HIV viral suppression (<1000 copies/ml, WHO's threshold for virologic failure in LMICs) versus not on ART or viral failure (≥1000 copies/ml). |
6 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of Participants With 12-month Viral Suppression
Periodo de tiempo: 12 months
|
The proportion of people living with HIV (PLHIV) retained in HIV primary care and with suppressed HIV viral load 12 months following study enrollment. The primary outcome is expressed as a binary variable, defined as PLHIV who are on ART and with sufficient HIV viral suppression (<1000 copies/ml, the World Health Organization (WHO) threshold for virologic failure in low- and middle-income countries (LMIC)) versus not on ART or viral failure (≥1000 copies/ml). |
12 months
|
|
Number of Participants With 12-month Durable Viral Suppression
Periodo de tiempo: 12 months
|
The proportion of people living with HIV (PLHIV) with durable HIV viral suppression at 12 months after study enrollment months (either: 1) ≥2 assessments of viral load, taken from up to 6 months prior to study enrollment and up to and including 12 months following study enrollment (the recommended timing of immunologic monitoring for stable PLHIV on ART with viral suppression), or 2) ≥3 assessments if baseline viral load is >1000 copies/ml (the recommended timing of immunologic monitoring mandates an additional follow-up assessment 3 months and again at 12 months) |
12 months
|
|
Total Number of Attended Visits Across All Scheduled Visits Between 0 to 6 Months
Periodo de tiempo: 6 months
|
Number of scheduled visits that were completed during the 0-6 month period |
6 months
|
|
Total Number of Attended Visits Across All Scheduled Visits Between 0 to 12 Months
Periodo de tiempo: 12 months
|
Number of scheduled visits attended between 0 and 12 months |
12 months
|
|
Incidence of Mortality at 12-month
Periodo de tiempo: 12 months
|
The cumulative incidence of all-cause mortality at 12 months after study enrollment |
12 months
|
|
Proportion of Participants Virally Suppressed Within 12-months
Periodo de tiempo: 12 months
|
Proportion of PLHIV with viral suppression in the 0-12-month follow-up period |
12 months
|
|
Number of Participants at 12-months Re-linked to HIV Care
Periodo de tiempo: 12 months
|
Number of participants re-linked to to HIV care over 0 to 12 months, after study enrollment |
12 months
|
|
Time to Re-linkage to HIV Care
Periodo de tiempo: 12 months
|
Time for patients to re-link back to HIV care |
12 months
|
|
Number of Participants at 6-months Retained in Care
Periodo de tiempo: 6 months
|
The number of people living with HIV (PLHIV) on ART at 6 months after study enrollment (PEPFAR considers those not retained on ART to include those who died, disengaged from care, stopped ART, or had no evidence of care for ≥28 days after a missed visit. Participants not found after exhaustive tracing efforts to rule out silent transfers will be classified as not retained on ART) |
6 months
|
|
Number of Participants at 12-months Retained in Care
Periodo de tiempo: 12 months
|
The proportion of people living with HIV (PLHIV) on ART at 12 months after study enrollment (PEPFAR considers those not retained on ART to include those who died, disengaged from care, stopped ART, or had no evidence of care for ≥28 days after a missed visit. Participants not found after exhaustive tracing efforts to rule out silent transfers will be classified as not retained on ART) |
12 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Jingshen Wang, PhD, University of California, Berkeley
- Investigador principal: Amon Sabasaba, MD, Health for a Prosperous Nation
Publicaciones y enlaces útiles
Publicaciones Generales
- Kadota JL, Packel LJ, Mlowe M, Ulenga N, Mwenda N, Njau PF, Dow WH, Wang J, Sabasaba A, McCoy SI. Rudi Kundini, Pamoja Kundini (RKPK): study protocol for a hybrid type 1 randomized effectiveness-implementation trial using data science and economic incentive strategies to strengthen the continuity of care among people living with HIV in Tanzania. Trials. 2024 Feb 10;25(1):114. doi: 10.1186/s13063-024-07960-x.
- Kadota JL, Packel LJ, Mlowe M, Ulenga N, Mwenda N, Njau PF, Dow WH, Wang J, Sabasaba A, McCoy SI. Rudi Kundini, Pamoja Kundini (RKPK): study protocol for a hybrid type 1 randomized effectiveness-implementation trial using data science and economic incentive strategies to strengthen the continuity of care among people living with HIV in Tanzania. Res Sq [Preprint]. 2023 Dec 20:rs.3.rs-3315136. doi: 10.21203/rs.3.rs-3315136/v1.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Infecciones transmitidas por la sangre
- Enfermedades urogenitales
- Enfermedades Genitales
- Enfermedades del sistema inmunológico
- Infecciones
- Infecciones por virus de ARN
- Enfermedades virales
- Enfermedades contagiosas
- Enfermedades De Transmisión Sexual Virales
- Enfermedades de transmisión sexual
- Infecciones por lentivirus
- Infecciones por retroviridae
- Síndromes de deficiencia inmunológica
- Enfermedades de virus lentos
- Infecciones por VIH
- Síndrome de inmunodeficiencia adquirida
Otros números de identificación del estudio
- R01MH125746 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Provided upon request
Criterios de acceso compartido de IPD
Provided upon request
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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